Safety Aid Reduction Treatment for Rural Veterans
START
Improving Access to Evidence Based Care Among Rural Veterans Using a Transdiagnostic Treatment Approach
1 other identifier
interventional
24
1 country
1
Brief Summary
The primary aim of the current proposal is to test the acceptability and feasibility of a group-based transdiagnostic treatment, termed Safety Aid Reduction Treatment (START), delivered to rural Veterans. The anticipated results of the proposed study include: 1) START will be both acceptable and feasible to Veterans and mental health care providers, alike and 2) START will lead to meaningful reductions in symptoms of anxiety and depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedStudy Start
First participant enrolled
April 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedMarch 2, 2020
February 1, 2020
12 months
July 12, 2017
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
START Qualitative Treatment Questionnaire
The START Qualitative Treatment Questionnaire is a brief, structured short-answer qualitative questionnaire that was developed by the research team to assess Veterans experience with the START protocol.
8 weeks
Secondary Outcomes (4)
Overall Anxiety Severity and Impairment Scale (OASIS)
Baseline and 8 weeks and 12 weeks
Overall Depression Severity and Impairment Scale (ODSIS)
Baseline and 8 weeks and 12 weeks
Safety Behavior Assessment Form (SBAF)
Baseline and 8 weeks and 12 weeks
Work and Social Adjustment Scale (WSAS)
Baseline and 8 weeks and 12 weeks
Study Arms (1)
START
EXPERIMENTALThe Safety Aid Reduction Treatment (START) protocol will consist of eight group sessions, delivered once weekly, lasting approximately one hour in duration. START will be delivered in-person by the PI and group co-leader.
Interventions
START includes many of the key elements found in empirically supported treatments for emotional disorders including a) psychoeducation regarding the nature of distress and b) exposure to internal sensations and external situations that are connected to one's distress response via identification and reduction in safety aids. Safety aids discussed in the current protocol include cognitive avoidance, situational avoidance, checking behaviors, reassurance seeking, avoidance of bodily sensations, companions, and use of alcohol and other substances.
Eligibility Criteria
You may qualify if:
- years of age and older
- Veterans must be diagnosed with an emotional disorder (e.g., anxiety disorder, obsessive-compulsive and related disorder, trauma-and stressor-related disorder, depressive disorder).
- And be primarily served at a CBOC location.
You may not qualify if:
- \< 18 years of age
- Currently dependent upon substances and in need of detoxification
- Evidence of active psychosis
- Acutely suicidal or homicidal
- Uncontrolled bipolar disorder (e.g., not stable on medications)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70112, United States
Related Publications (4)
Veterans Health Administration Office of Rural Health. ORH Fact Sheet. 2014; Available from: http://www.ruralhealth.va.gov.
BACKGROUNDAllen, L.B., R.K. McHugh, and D.H. Barlow, Emotional disorders: A unified protocol. 2008.
BACKGROUNDSchmidt NB, Buckner JD, Pusser A, Woolaway-Bickel K, Preston JL, Norr A. Randomized controlled trial of false safety behavior elimination therapy: a unified cognitive behavioral treatment for anxiety psychopathology. Behav Ther. 2012 Sep;43(3):518-32. doi: 10.1016/j.beth.2012.02.004. Epub 2012 Mar 9.
PMID: 22697441BACKGROUNDRiccardi CJ, Korte KJ, Schmidt NB. False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. J Anxiety Disord. 2017 Mar;46:35-45. doi: 10.1016/j.janxdis.2016.06.003. Epub 2016 Jun 18.
PMID: 27397584BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda M. Raines, Ph.D.
Southeast Louisiana Veterans Health Care System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychologist
Study Record Dates
First Submitted
July 12, 2017
First Posted
September 18, 2017
Study Start
April 16, 2018
Primary Completion
April 2, 2019
Study Completion
April 30, 2019
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
Data sets underlying this project will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA), for a number of reasons. First, data will be used by the research team to answer additional research questions. Further, veterans may be hesitant to participate in research in which the data will be shared outside the VA and this may act as a barrier to participation and/or benefit from treatment.